Non-interventional Study, Long Term Treatment on Glabellar Lines With Dysport® in Subjects of Chinese Origin

Galderma

Status: Completed

Conditions: Glabellar Lines

Treatments: Biological: AbobotulinumtoxinA

Study type: Observational

Funder types: Industry

Identifiers

NCT05089357

05PF2009

Details and patient eligibility

About

This is a prospective, longitudinal, non-interventional, multi-center study to collect subject and physician satisfaction, and treatment experience with Dysport in real clinical practice in subjects of Chinese origin.

Full description

Approximately 250 subjects are planned to be included in the study.

Enrollment: 250 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult male or female up to 65 years of age, and of Chinese origin.
• Moderate (grade 2) or severe (grade 3) glabellar lines at max frown.
• Prior to and independent of study, subject is seeking long term treatment of their glabellar lines.
• Prior to and independent of the study participation, physician intended to treat the subject with Dysport.
• Time and ability to complete the study and comply with instructions.
• Understands the study requirements and signed the informed consent form (ICF)

Exclusion criteria

• Hypersensitive to Dysport or its excipients.
• Presence of contraindications to Dysport treatment as specified in the approved leaflet in China.
• Subject is at risk for precautions, warnings, and/or contraindications to Dysport as specified in the approved leaflet in China.

Trial design

250 participants in 1 patient group

AbobotulinumtoxinA

Description:

Participants with moderate to severe GL received a total dose of AbobotulinumtoxinA (Dysport®), 50 U (0.25 mL total; 10 U \[0.05 mL per injection site\] of study drug into 5 injection sites intramuscularly: 2 injections into each corrugator muscle and 1 injection into the procerus muscle) at Visits 1, 3, and 5.

Treatment:

Biological: AbobotulinumtoxinA